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NCT01103492 · ClinicalTrials.gov registry record · NA
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System
A NA study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT01103492: Completed NA study, sponsored by University Hospitals Cleveland Medical Center.
NCT01103492 is a NA study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01103492, a NA study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study involves evaluating a procedure in which the study device, the HALO90 Ablation catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF) energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining of the rectum caused by the side effects of radiation treatments that can lead to bleeding). In medical procedures, the RF energy used with this device, has been historically used in shrinking or removing soft-tissue, for surgical cutting, and for stopping bleeding. The device is cleared by the Food and Drug Administration (FDA) for use in coagulation (to assit with stoping bleeding and clotting of blood) of tissue within the digestive tract. The device has been used in areas outside the esophagus (inner lining of the throat), including the rectum to treat radiation proctitis. The stoppage of bleeding of radiation proctitis, using the HALO device, may be one method to control the bleeding. The purpose of this study is to evaluate the effectiveness and record the results of treatment of radiation proctitis using the HALO device.
Primary Outcome
As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.
Interventions
- DEVICE HALO90 Ablation catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-06 |
| Phase | NA |
What the finished NCT01103492 record still lists
NCT01103492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which HALO90 Ablation catheter is the first listed.
NCT01103492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01103492 about?
NCT01103492 is a clinical study titled "Treatment of Hemorrhagic Radiation Proctitis Using the Halo System". This study involves evaluating a procedure in which the study device, the HALO90 Ablation catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF) energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining of the rectum caused by...
What is the current status of trial NCT01103492?
This trial is currently completed. It is a NA study. The enrollment target is 1 participants. The study started on 2008-07. Estimated completion is 2009-06.
What interventions are being tested in trial NCT01103492?
The interventions under investigation include: HALO90 Ablation catheter (DEVICE).
Who is sponsoring clinical trial NCT01103492?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01103492's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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